Tag Archives: biologics

In a move last month that apparently took at least two device manufacturers completely by surprise, one center of the Food and Drug Administration recommended against an intended use of their products, despite the products’ approval and licensure by another FDA center.

PharmaJet's Stratis is used to vaccinate a Cambodian child against measles. Photo courtesy of Heather Potters.

Recent jet injector models, including Bioject’s ZetaJet and Biojector 2000 and PharmaJet’s Stratis, were approved and licensed by the FDA’s Center for Devices and Radiological Health (CDRH) as needle-free alternatives for injecting vaccines and injectable medications. Both companies had been marketing their devices for influenza immunization in the current flu season.

On October 26th, the FDA’s Center for Biologics Evaluation and Research (CBER) issued a notice advising healthcare professionals that inactivated influenza vaccines should be administered only with a sterile needle and syringe. The reason: “Safety and effectiveness information that would support labeling inactivated influenza vaccines for delivery by jet injector have not been submitted to FDA.” However, CBER said, individuals who have already received a flu vaccine with a jet injector do not need to be revaccinated.

Currently, only the measles-mumps-rubella vaccine is approved and specifically labeled for administration by jet injector.

So what’s the concern with influenza vaccine? “A jet injector subjects the vaccine to a different pressure than it would receive during administration by sterile needle and syringe and as a result the effectiveness and the safety profile of the injected vaccine may be altered,” according to the CBER document.

Evidently this information had not been previously communicated to the manufacturers. “We were provided no notice by FDA of any concerns about Jet Injectors or FDA’s statement. To our knowledge, no other needle-free injection manufacturer received notice or an opportunity to discuss this matter with FDA,” PharmaJet said in a statement.

Bioject’s President and CEO Ralph Makar was similarly taken aback by the FDA notice. “The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices…are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs,” he said in a statement.

In a public comment at the October meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, PharmaJet Inc’s chairman Heather Potters said, “Last year we scaled up to provide several hundred thousand syringes, and this season we were expecting to sell several million. Now, our domestic sales have virtually stopped, except for [investigational trials].”

The companies are expected to meet with the FDA in early January to work this out. According to Mr. Makar, “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”

That’s the question Dr. Kenneth Gordon of the Pritzker School at the University of Chicago posed to colleagues at the American Academy of Dermatology’s annual meeting in New Orleans. It was not meant to be rhetorical.

Given the huge pressure to use the new therapies – from patients, pharmaceutical manufacturers, and in some cases, the dermatologist’s own desire to use what appears to be the latest and greatest – there are a lot of potential costs.

Via Flickr Creative Commons user walknboston

The drugs, which include Amevive (alefacept), Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), and Stelara (ustekinumab), are hugely expensive (for a list of these drugs and their mechanisms, go here). Plus, there is a human cost – many of these biologics have the potential to cause infections, demyelinating disorders like multiple sclerosis, and cancer.

Psoriasis is a lifelong disease, and thus, therapies are taken more or less for life, noted Dr. Gordon, who also heads dermatology at the Northshore University Health System. But what is known about the long term safety of these biologics? There is little-to-no data beyond trial periods of 12-24 weeks in psoriasis patients. And although some of the drugs have been studied for longer in rheumatoid arthritis, Dr. Gordon said that it is not instructional to extrapolate the data to psoriasis.

When the first biologic came on the market in 2003, there was a great deal of excitement, he said. At that time, at least half of patients he treated were on methotrexate.

In his presentation, Dr. Gordon delved through the available data on efficacy and long term safety of older therapies like methotrexate, acitretin, and cyclosporine, and compared that to the biologics’ track record. So far, though there’s a big gap between knowledge and use for both the older and newer therapies.

What he concluded was that for moderate-to-severe patients, biologics probably pack a more powerful punch. Methotrexate is still a first-line choice for many psoriasis patients in his practice who are not as ill, but he says he still thinks of the drug as having had its heyday in the 1970s.

Where do biologics fit in your practice? Have your patients been better off since the advent of the therapies?

If by 12 weeks, you have no response at all, then it’s time to change. If, on the other hand, by 12 weeks you have a little response — just the begining of a change in the DAS [disease activity score], etc. — then it really makes sense to wait another 8-12 weeks before deciding to go to a different mechanism of action.